USA approves new drug for Alzheimer’s disease in 20 years

The new treatment for Alzheimer’s disease has been approved by the regulators of USA nearly after 20 years.

This approval will trigger pressure to make it available worldwide despite of its mixed evidence over its efficacy.

Aducanumab targets the Underlying cause of Alzheimer’s, the most common form of dementia.

Food and Drug Administration (FDA) of USA said :

There was “substantial evidence that aducanumab reduces amyloid beta plaques in the brain” and that this “is reasonably likely to predict important benefits to patients”.

There are about 30 million people around the globe thought to have Alzheimer’s, mostly aged above 65.

The US Food and Drug Administration (FDA) has now approved the drug, but only on condition that those given it are part of what is called a phase 4 trial.

This means they will be monitored by researchers to see how well they do on the drug and whether it really does slow the progression of mental decline.

For around 500,000 people affected in the UK, those eligible for aducanumab will be mostly in their 60s or 70s and at an early stage of the disease.

About Aducanumab

Aducanumab is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.

It is approved under the accelerated approval pathway, which provides patients suffering from a serious disease earlier access to drugs when there is an expectation of clinical benefit despite some uncertainty about the clinical benefit of the drug.

Accelerated approval is based upon the drug’s effect on what is called a “surrogate” endpoint— an endpoint that reflects the effect of the drug on an important aspect of the disease—where the drug’s effect on the surrogate endpoint is expected, but not established, to predict clinical benefit.

In the case of Aducanumab, the surrogate endpoint is the reduction of amyloid beta plaque.